Press Release

NeoImmuneTech Announces First Patient Dosed in Phase 2 Study of NT-I7 (efineptakin alfa) in combination with PD-L1 checkpoint inhibitor in Frontline Locally Advanced or Metastatic Non-Small Cell Lung Cancer

NeoImmuneTech, Inc. (KOSDAQ: 950220), a clinical-stage T cell-focused biopharmaceutical company, today announced that the first patient has been dosed in a Phase 2 study evaluating NT-I7 (efineptakin alfa), a novel long-acting human interleukin-7 (IL-7), in combination with atezolizumab (Tecentriq®) as a first-line (1L) treatment for patients with PD-L1-expressing, locally advanced or metastatic non-small cell lung cancer (NSCLC).

NSCLC accounts for approximately 85% of all cases of lung cancer. Lung cancer is the second most commonly diagnosed cancer worldwide – in 2020, an estimated 2.2 million new cases of lung cancer were diagnosed globally, accounting for approximately 11.4% of the global cancer burden. An estimated 1.8 million lung cancer deaths occurred in 2020[1]. Atezolizumab has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in the US. Atezolizumab now has five approved indications in NSCLC in the US, including as a single agent or in combination with targeted therapies and/or chemotherapies. It was also the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy) and the first approved cancer immunotherapy for adjuvant NSCLC.

“Following preclinical studies which showed promising evidence that adding NT-I7 to atezolizumab increased the anti-tumor activity, we are pleased to have commenced this Phase 2 trial,” said Se Hwan Yang, Ph.D., President and Chief Executive Officer of NIT. “NT-I7’s T cell-amplifying properties may make it an excellent partner in combination with a checkpoint inhibitor, like atezolizumab, and this study could bring us closer to a new chemo-free treatment option for patients with PD-L1-expressing NSCLC. We look forward to evaluating how the addition of NT-I7 impacts the effects of single-agent atezolizumab in frontline locally advanced or metastatic NSCLC.”

This multicenter Phase 2 study will evaluate the efficacy and safety of the combination therapy. Roche will supply NeoImmuneTech with atezolizumab for the clinical trial. More information can be found at www.neoimmunetech.com or www.clinicaltrials.gov, identifier: NCT04984811.

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About NT-I7

NT-I7 (efineptakin alfa) is the only clinical-stage long-acting human IL-7, and is being developed for oncologic and immunologic indications, in which T cell amplification and enhanced functionality may provide clinical benefit. IL-7 is a fundamental cytokine for naïve and memory T cell development and for sustaining immune response to chronic antigens (as in cancer) or foreign antigens (as in infectious diseases). In clinical trials to date, NT-I7 has exhibited favorable PK/PD and safety profiles, both as a monotherapy and in combination with other anticancer treatments. NT-I7 is being studied in multiple clinical trials in solid tumors and as a vaccine adjuvant. Studies are being planned for testing in hematologic malignancies, additional solid tumors and other immunology-focused indications.

About NeoImmuneTech

NeoImmuneTech, Inc. (NIT) is a clinical-stage T cell-focused biopharmaceutical company, dedicated to expanding the horizon of immuno-oncology and enhancing immunity to infectious diseases. NIT is led by the scientific founder and inventor of NT-I7 (efineptakin alfa) and complemented by a strong executive team with rich industry experience at companies such as Novartis, BMS, GSK, Pfizer, Amgen, Eli Lilly, MedImmune/AstraZeneca and PwC. NIT is expanding rapidly in personnel and operations, as well as partnering with industry and academic leaders to investigate NT-I7 as monotherapy and in combination with various immunotherapeutics. For more information, please visit www.neoimmunetech.com.

Forward-looking Statements

The statements contained herein may contain certain forward-looking statements relating to NeoImmuneTech, Inc. (the “Company”) that are based on its beliefs and expectations about the future. These forward-looking statements are based on a number of assumptions about the future, some of which are beyond the Company’s control and are not a guarantee of future performance or developments. Such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those contemplated by the relevant forward-looking statements. The Company does not undertake any obligation to update any forward-looking statements to reflect events that occur or circumstances that arise after the date of these documents. Accordingly, you should not place reliance on any forward-looking information or statements contained herein.

Some of the data contained in these documents were obtained from various external sources, and the Company has not independently verified such data. Accordingly, the Company makes no representations as to the accuracy or completeness of the data, and such data involves risks and uncertainties, and is subject to change based on various factors.
 
[1] Medscape. (2021, July 17). https://www.medscape.com/answers/279960-84979/what-is-the-global-prevalence-of-nonsmall-cell-lung-cancer-nsclc.
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